phenox GmbH

phenox GmbH specializes in endovascular devices used to treat cerebral aneurysms. Their portfolio includes bifurcation aneurysm implants, which are designed to occlude or stabilize aneurysms at branching points in blood vessels, and flow modulation devices that regulate blood flow within aneurysms to lower the risk of rupture. These devices are tailored for specific anatomical and clinical needs, such as high-pressure configurations.

phenox GmbH is headquartered in Germany. The company develops its devices in compliance with EU medical device regulations, ensuring adherence to standards that govern safety, performance, and quality. This includes registration in the EU’s eudamed database, which tracks medical devices authorized for use within the European market.

phenox GmbH’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is mandated for all Class I and Class II/III devices authorized in the European Economic Area (EEA). Since some of their aneurysm implants fall under Class III—due to their high-risk nature and direct involvement in life-sustaining or critical procedures—they must be registered here to demonstrate compliance with EU medical device legislation.

phenox GmbH’s devices are classified as Class I (lower-risk products) and Class III (high-risk, life-critical devices) under EU medical device regulations. The Class III designation applies to their aneurysm implants and flow modulation devices because they are implanted in the body, pose significant risks if they fail, and require rigorous pre-market evaluation—such as clinical data and conformity assessments—to ensure safety and efficacy. This classification ensures stricter oversight and authorization processes.